The Journal 12.06am, 7 Jun 2025

OACS Ireland are grateful to “The Journal” and all journalists who have helped us highlight our cause!

It has been almost a year since a chairperson was appointed to lead the inquiry into the historical licensing and use of the drug.

THE CHAIR OF an advocacy group for families affected by an antiepileptic drug that can cause serious birth defects if used during pregnancy is seeking a meeting with the Minister for Health to discuss why an inquiry into the drug has yet to begin. 

The inquiry into the historical licensing and use of the drug was approved by Cabinet in July 2023, almost three years after the then-health minister Stephen Donnelly committed to holding a probe into the drug. 

Last June, barrister and mediator Bríd Flaherty was announced as the chairperson of the non-statutory inquiry, with Donnelly saying at the time that he intended to get it up and running “in a matter of weeks“.

But since then, there has been no indication of when it will get underway.

The Organisation for Anticonvulsant Syndromes (OACS) Ireland group, which supports families that have been impacted by the drug, is seeking a meeting with Health Minister Jennifer Carroll MacNeill to discuss the status of the inquiry. 

Solicitor Ciara McPhillips, who represents OACS Ireland within the inquiry process, told The Journal that the families feel disappointed, angry and “that they have now been forgotten about”.

“They feel that they were led to believe that this inquiry was absolutely imminent, that the appointment of a chair last summer meant that real progress was being made, that the log jams had all been cleared, and that there was a smooth path ahead, and that clearly has not been the case,” she said. 

She believes that getting the inquiry underway in the next six months “ought to be achievable”.

“But at this stage, like the families, I am fast losing faith as to when this will all take place.

Whilst I might have thought the ‘weeks’ promised by the previous minister was overly enthusiastic on his part, a year, on the other hand, seems unnecessarily and inexcusably slow.

A spokesperson for the Department of Health confirmed to The Journal that they received correspondence from OACS Ireland requesting a meeting with the Minister in recent days, adding: “This is being reviewed with regard to scheduling.”

Sodium valproate can cause serious birth defects and developmental disorders to an infant if taken during pregnancy and women have been advised against using it unless no other treatment is possible.

The drug was prescribed in Ireland and elsewhere for years after the danger was discovered and many countries are now investigating its use.

Today, the Health Products Regulatory Authority (HPRA) states that the drug can cause birth defects and problems with the development and learning of the child if their mother takes it during pregnancy.

Children exposed to the drug while in the womb are at a high risk of serious developmental disorders (in up to 30-40% of cases) and congenital malformations (in approximately 10% of cases).

Symptoms of fetal valproate syndrome (FVS) vary, but can include characteristic facial features, spina bifida, congenital heart defects, cleft lip and/or cleft palate, genital abnormalities, skeletal abnormalities and developmental delay. 

The drug’s risk to infants has been made public in recent years, but campaigners in the UK found documents in the National Archives that indicated health regulators were aware of the risk as far back as 1973 but chose not to warn patients, saying it “could give rise to fruitless anxiety”.

A HSE report published in 2018 estimated that 1,250 children have been affected by valproate since 1975 in Ireland.

In 2021, an investigation by The Journal Investigates found that around 3,000 Irish children were potentially harmed by exposure to the drug in the womb.

• Read The Journal Investigates’s investigation into the valproate scandal.

Last January, doctors began informing men of the potential risks that taking sodium valproate can have on their future children before prescribing it to them following precautionary measures recommended by the European Medicines Agency. 

The Department of Health previously said that the inquiry will document the evolution of the drug’s regulation in Ireland, practices and controls in relation to prescribing and dispensing, and the timeline of developments in scientific knowledge about the potential impact of the drug on fetal development.

Sinn Féin’s health spokesperson David Cullinane last week asked the Health Minister about the status of the inquiry in a parliamentary question. 

Data regulations

In response, Carroll MacNeill said that “significant work has been carried out to put in place the necessary arrangements to operationalise and establish the inquiry” since the chair was appointed last June.

In a statement to The Journal, a spokesperson for the Department said before the inquiry can commence, “it is necessary to have in place regulations made under the Data Protection Act 2018, to ensure that there is a robust legal basis supporting the work of the inquiry and that data protection obligations are appropriately supported”. 

“The Department of Health continues in its cross-Government collaborations to draft the necessary Statutory Instruments to provide this robust legal basis as a priority,” the spokesperson said. 

“When these have been finalised, it is anticipated that the public-facing elements of the inquiry will commence shortly thereafter.”

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But McPhillips told The Journal that the length of time it has taken to draft data regulations seems “unusual” to her.

“As a solicitor who deals in medical and clinical evidence claims, we deal with individuals medical records on a daily basis, and we deal with different hospitals and different state bodies in terms of accessing individuals records. I would have thought that the State had very good knowledge and understanding of this,” she said. 

“Obviously the families want the data regulations to be stringent and properly in place, because it’s their data that will be at the center of this inquiry. But at the same time, to most families, it seems incredible that it would take this long to sort something like data regulations.”

McPhillips said the State has run “numerous inquiries” in recent years, and data protection laws “have not changed in the last number of months”.

“‘What makes this inquiry different to others’ is the question, and therefore, from that is bred the belief that there isn’t actually a want to progress the inquiry, and that is a real source of frustration.”

Karen Keely, the chair of OACS Ireland, told The Journal that waiting for the inquiry has been “painful” and “pure mental torture” for families who have been waiting years for a probe into the drug. 

“We’re literally banging our head off a brick wall, because we feel that this is not a priority for the Minister,” she said.

This is precious time. They’re wasting precious time that we could be spending with our sons and daughters. We thought we’d literally be halfway through the inquiry by now.

Keely has three adult sons who have been affected by exposure to sodium valproate. She said the drug “destroyed my family”. 

She sent letters to the Health Minister in March and April, and received a response at the end of May in which the Minister assured her of “my best intentions on this matter”. 

She said that she and the other OACS Ireland board members ”would greatly appreciate the opportunity to meet with the Minister at the earliest convenience”.

“The current situation has been extremely stressful, which can be detrimental to our well-being, particularly for those affected by epilepsy.”

Keely added: “What I want out of this inquiry, and what any mother would want, is accountability, an apology and redress. It’s as simple as that.”

With reporting from Maria Delaney

OACS Ireland are grateful to “The Journal” and all journalists who have helped us highlight our cause!